652 Clinical Trials Jobs - Page 6

Key Responsibilities Design statistical analysis plans for clinical trialsobservational studiesand laboratory experiments. Perform statistical analyses using appropriate software (e.g.SASRPython). Collaborate with clinical researchersdata managersand regulatory teams to ensure data integrity and compliance. Interpret and communicate statistical results clearly to cross-functional teams and stakeholders. Prepare tableslistingsand figures for clinical study reports and publications. Support the preparation of documents for regulatory submissions (e.g.FDAEMA). Stay current with advancements in biostatistics and relevant regulatory guidelines. Contribute to protocol developmentdata monitoringand interim analysis. Provide statistical consulting to internal teams on study design and methodology.

At Quanticate, were pioneers in providing top-tier statistical and data management support to our clients. Were seeking a dedicated "Clinical Data Manager I" whos committed to upholding the highest standards, following procedures, and ensuring compliance with regulations, all while providing exceptional customer care. As a "Clinical Data Manager I" you will lead, co-ordinate, and action all tasks relating to Clinical Data Management from the start to the finish of a study to project manage studies across CDM functions. Core Accountabilities: Activities required of a Clinical Data Manager I (however not restricted to) are as below: To contribute to the efficient running of the CDM department as part of the CDM leadership team. Ensure launch, delivery, and completion of all CDM procedures according to contractual agreement and relevant SOPs, guidelines, and regulations To pro-actively keep abreast of current clinical data management developments and systems To assist in the creation and review of in-house SOPs. To research and provide input into in-house strategies and systems. To perform medical coding activities on projects, if assigned. To perform other reasonable tasks as requested by management. Ensure consistency of process and quality across projects. Project management for allocated projects: To help plan and manage study timelines and resources. To manage progress against schedules and report to management. To perform project management across all functions for a study as appropriate. Management of CRFs and all related tasks Management of allocated staff: Allocation of projects in conjunction with Project Management, as appropriate Performance reviews, as required. Administer training and development of staff, as required. Key Relationships: Act as the primary CDM contact, both external and internal, for Quanticate projects. Manage work assignment and delivery of project tasks to the data processing and programming team as required Line management responsibilities for any assigned direct reports, including professional development/training and performance appraisals. Qualified to an appropriate standard, preferably to degree level in a life sciences subject Four to seven years of relevant experience in CRO Clinical Data Management domain. Extensive knowledge of

Overview We have an exciting role of Manager - Medical Copywriter to drive and translate creative and contemporary ideas to solid design and impact. You will have a key role in design and deployment of creative campaigns with our global clients, including many Fortune 50 companies. About US We are an integral part of Annalect Global and Omnicom Group, one of the largest media and advertising agency holding companies in the world. Omnicom’s branded networks and numerous specialty firms provide advertising, strategic media planning and buying, digital and interactive marketing, direct and promotional marketing, public relations, and other specialty communications services. Our agency brands are consistently recognized as being among the world’s creative best. Annalect India plays a key role for our group companies by providing stellar products and services in areas of Creative Services, Technology, Marketing Science (data & analytics), Market Research, Business Support Services, Media Services, Consulting & Advisory Services. We are growing rapidly and looking for talented professionals like you to be part of this journey. Let us build this, together! Responsibilities This is an exciting role and would entail you to Manage cross-functional partners to deliver medical content for a variety of audiences (digital and print) while also handling medical copywriting and veeva submissions work Copywriting & Content Development Write clear, engaging, and medically accurate content for a range of audiences - including press materials, consumer campaigns, digital assets, and educational tools. •Translate complex clinical and scientific information into language that resonates with non- specialist audiences, including patients, caregivers, and media outlets. Develop a refined understanding of the brand, disease, and the overall therapeutic/treatment category Ensure the creation of all content is developed with appropriate tone, style, and structure based on brand strategy, creative brief, and client expectations Develop messaging that aligns with brand strategy, while simplifying technical data for broader understanding without compromising accuracy. Partner with internal teams (account, strategy, and creative) to ideate and execute content that is impactful, on-brand, and compliant. Revise and refine copy based on internal and client feedback and MLR reviewer input. Veeva Submission & MLR Review Support Prepare and submit materials in Veeva Vault PromoMats for MLR review, ensuring all metadata, references, and annotations are accurate and complete. Link supporting references to corresponding claims and manage annotation accuracy. •Track submission timelines and status; coordinate follow-ups, revisions, and final approvals. •Act as a bridge between creative/content teams and regulatory operations to ensure seamless submissions and compliance with SOPs. Maintain organized version control and documentation of submitted and approved materials Demonstrate an understanding of healthcare/pharma advertising communication requirements Be familiar with modular content and omnichannel marketing – develop and maintain content matrix and core claims documentation Qualifications You will be working closely with Our global creative agency teams. You will also be closely collaborating with our team of talented and designers to deliver high-quality services. This may be the right role for you if you have 11+ years of experience in healthcare communications agencies (AMA experience is preferred) Bachelor's degree or equivalent experience with a focus on pharma/science/medicine Portfolio containing work samples that demonstrate strong conceptual abilities, creative thinking, and exceptional writing skills in a variety of communication forms (e.g., sales aids, direct mail, websites, social media) for a variety of audiences (e.g., healthcare professionals, patients, consumers) Understanding of omnichannel marketing, modular content, and processes for content development Experience with referencing and annotating, and MLR submissions requirements and processes Excellent leadership, management and client-facing communication skills Strong organizational skills, attention to detail, and ability to multitask. An ability to understand and process healthcare information Ability to multi-task in a faced-paced environment as a member of a highly collaborative team The desire to work with a diverse group of teams, projects, and clients.

We are hiring a Business Analyst for the Bangalore location in a Hybrid mode. Role Overview The Business Analyst role is focused on the clinical domain, requiring strong knowledge of clinical trials, clinical research associates, investigators, and subjects (patients). The candidate should be familiar with Electronic Data Capture (EDC) systems and Clinical Research Forms (CRFs). Key Requirements and Skills: SQL Knowledge : The candidate should have a basic understanding of SQL queries. Clinical Domain Expertise : Strong knowledge in clinical trials and related processes. Business Analyst Skills : Understanding of business goals, Agile methodology, and waterfall methodology. Technical Skills : Experience with JIRA, TopTeam, SynapseRT, and proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Project, and Visio). Writing Skills : Strong technical and business writing skills, including knowledge of technical and grammatical editing. Communication Skills : Ability to communicate technical concepts to non-technical audiences and business concepts to technical audiences. Modelling Languages : Ability to learn and use modelling languages when required. Negotiation and Customer Management : Skills in negotiation and customer management. If interested, drop your profile at nusrath.begum@priglobal.com along with the following details: Total Experience: Current CTC: Expected CTC: Notice Period:

*Greetings From You & I Consulting ! You & I Consulting has always been in the spotlight for getting placed in 64+ MNC's PAN India. *Hurry Do Not Miss This Opportunity To Work For Global Giant MNC. We are hiring for the below locations under Medical Reviewer Role!! *Open Locations :- * Pune/ / Chennai / Mumbai *Mode Of Interview - Virtual *Mode Of Work :- Work From Office * CTC Upto - 10 To 24Lpa *Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) or email your CV to puja@careersuni.com PFB Job Insights for Medical Reviewer Role!! Author a CCC for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. Detail any requests for changes to the case, including the narrative. Skills required:- Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills * * *Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) email your CV to puja@careersuni.com ***Note we also have open positions for the below skills :- * * *Call Now our HR Specialist for more details:- @ puja - 8250242229 (call or whts app) email your CV to puja@careersuni.com *Aggregate Reporting / Clinical Data Management / Clinical SAS / SQL Programmer / EDC Programmer / Medical Monitor / HEOR Health Economist Role / SAS + R / Statistical Programmer / Study Data Manager *Though We Try and Answer The Calls Immediately, but Due to Heavy Call Flow The Below Numbers Might Be Busy At Times. In case you find the number busy, please whatsapp your details to us in the below format: - Name- Mobile number - Mail - Qualification - Total work experience - Current Organization- Location - Last CTC Expected CTC:- *Interested candidates can even refer their friends or relatives provided the criteria *FOR interview Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) email your CV to puja@careersuni.com

ob DescriptionJob Description Are you looking for a meaningful and fulfilling career in Project Management within the Clinical Research industry? Join Clario's Medical Imaging team in Bengaluru, India, and be part of a legacy with over 30 years of expertise. We specialize in providing seamless, secure, and compliant medical imaging solutions that enhance clinical trials. At Clario, we have ambitious goals and a clear vision for the future. This is your chance to be part of our journey as an Assistant Clinical Project Manager. What we offer Competitive compensation Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What you'll be doing Assists Clinical Project Managers with project administration by: Developing project related documents Reviewing and editing project presentations Participating in project meetings, conference calls, and training calls Reading and understanding project protocol documents Acting as a liaison with cross-functional team members to ensure timely completion of all study deliverables. Reporting study needs and issues Supporting overall project start-up, execution and close out activities Supporting project finance-related activities such as: Assistance with documentation / database updates due to project scope changes Follow-up related to invoice reconciliations. Preparation of project reports in support of project forecasting activities Assists Clinical Project Managers in maintaining, reviewing, and communicating project progress by: Monitoring internal data flow to ensure completion of tasks within agreed upon timeframes Responding to inquiries in a professional, courteous, and timely manner Communicating with clients regarding project status Verifying protocol imaging requirements are met and queries appropriately identified Serving as acting Project Manager in the absence of the assigned Project Manager Creating, reviewing, and distributing (internally and/or externally) project report(s) Ensures the development and adherence to project timelines by: Following up on outstanding items including missing data, incomplete paperwork, queries, etc. Assisting in tracking and resolving of client issues Serving as additional point of contact to client, sites, sponsors, etc. Supporting Logistics with the distribution, management and tracking of site-facing materials Keeping clinical project manager(s) (CPM) and supervisor advised of current issues Maintains Quality Service and Departmental Standards by Reading, understanding, and adhering to organizational Standard Operating Procedures (SOPs) Executing technical and clinical functions as required by the study protocol in accordance with Clarios GCP’s, ICH and FDA Guidelines. Reviewing and providing recommendations to management on operational procedures, and by participating in process improvement initiatives. What we look for Bachelor’s Degree preferred 1 + years of experience working in pharmaceutical drug development, clinical trials, and/or clinical research preferred Strong experience with and knowledge of the Microsoft Office suite of software productivity tools Healthcare, medical experience, and/or clinical research, preferred Strong organizational, interpersonal, time management, and prioritization skills Excellent interpersonal, verbal and written communication skills, including ability to communicate effectively in English Detail oriented, meticulous, and responsive to inquiries and requests Ability to work independently, and to collaborate in a team setting Ability to deal with uncertainty, and adapt to changing priorities Pragmatic, proactive and goal oriented Ability to project and maintain a professional and positive attitude.

Job DescriptionJob Description Are you seeking a purposeful and rewarding Project Management career opportunity within a team dedicated to specialty solutions for clinical trials? Our Clinical Adjudication team is expanding in India, and with ambitious goals and a clear vision for the future, now is the perfect time to join Clario as a Clinical Project Manager. In this role, you will be part of a team dedicated to ensuring unbiased and standardized evaluation of clinical trial events, contributing to the credibility and success of our studies. Join us and make a meaningful impact in the field of clinical research. What we offer Competitive compensation + shift allowances Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What you'll be doing Identifies project guidelines and communication needs by: Reviewing study requirements and response assessment criteria and collaborates with key stakeholders to develop study start-up activities and associated documents Defining project plans (i.e. timelines, milestones and limitations for project staff) Establishing project reporting schedules Providing project updates to BD Director, Global Services Managing Directors, Sponsor representative(s) on schedule Communicating timely, appropriate project information to project teams, sites and company/sponsor representative(s) Performs project analysis and management by: Identifying critical project success factors for tracking, analysis and reporting Determining needed resources for project completion and communicating needs to appropriate departmental managers Collaborating with department leaders for appropriate training of those involved with the project toward excellence in successful and timely completion of project Performing financial tasks including monthly billing, forecasting, project scope reviews and amendments, and pass-through cost management Possessing a thorough understanding of the project contract and totals needed for monthly revenue reporting Understanding SOPs and working closely with QA for clarification and documentation of deviations Training and maintaining project team knowledge and applications of SOPs Communicating all protocol clarifications/revisions to project team Coordinating site management of data collection with internal and external teams Provides project team leadership by: Leading by example with professional and collaborative conduct Developing and delivering team project training Establishing team performance expectations and guidelines Providing input to departmental managers of respective team members performance level Analyzing team performance for consistency/quality within established project guidelines Collaborating with the departmental managers for team coaching/mentoring Supports Business Development efforts by: Collaborating with BD Director in the development and presentation of company capabilities calls/meetings Attending professional meeting(s) as Company representative Delivering polished Investigator Meeting presentation projecting solid comprehension of project/protocol and company services Oversees project close out by: Assisting with coordination of submission activities, as applicable Assisting with initiating and overseeing all project close out activities to completion Performs supervisory functions by, if applicable: Communicating job expectations Planning, monitoring and appraising job results Coaching, counseling and disciplining staff Initiating, coordinating and enforcing systems, policies and procedures Approving direct reports time sheets, requests for time off and/or overtime Performing timely performance evaluations of direct reports Coordinating and conducting new hire interviews; facilitating hiring decision Training new hires on departmental processes and responsibilities Maintains Quality Service and Departmental Standards by: Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”) Establishing and enforcing departmental standards Reviewing and updating company SOPs related What we look for Bachelor’s degree required or commensurate experience level. Educational majors in life sciences, pharmacy, nursing, or other healthcare field highly desirable Previous management or project experience in clinical development of investigational medications required 1-3 years clinical trials experience within a CRO or pharmaceutical research organization required; preferably in a project management related role. Working knowledge of GCH, ICH guidelines and FDA regulations Clinical Adjudication experience a plus Experience working with computer software including Word, Excel, Access and Project preferred Strong interpersonal and communication skills, both verbal and written Strong organizational and leadership skills Goal oriented Ability to maintain professional and positive attitude At Clario, we put people first, always. We are united and driven by patients, committed to making a difference, and we are always looking for the best talent to help us transform lives. We value the contribution each of our people brings. It’s only through our people that we can continue to innovate technology that will shape the future of clinical trials.

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Affiliate Team AssociateAffiliate Team Associate Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: BSc/Bachelor of Pharmacy Years of Experience: 0 to 1 years Language - Ability: English(International) - Proficient About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification BSc,Bachelor of Pharmacy

QC and formatting of clinical trial protocols, informed consent forms (ICFs), clinical study reports (CSRs), investigator’s brochures (IBs), and clinical data summaries for phase 1-phase 3 and post-marketing surveillance studies and as per agreed timelines. QC and formatting of clinical modules of eCTD dossiers for global approval in developed and emerging markets with high quality and as per agreed timelines. Ad-hoc writing support for clinical documents such a ICFs, CSRs and protocols CSR publishing for regulatory submissions. Ad hoc QC and formatting support for cross-functional teams in Medical Affairs and Clinical Development Support in creating and/or updating SOPs, checklists, and templates. Work collaboratively with other medical writers and cross-functional stakeholders within the Clinical Development function. Support Group Lead in maintaining and tracking medical writer occupancy and resourcing Qualification M Pharm with minimum 5 years of experience in document QC and formatting within the pharmaceutical industry Excellent written, spoken, interpersonal and presentation skills Proficiency in editing and formatting documents using Microsoft Office and Acrobat. Good understanding of medical terms, clinical trials, and drug development process. Ability to analyze and interpret scientific and medical data Highly detailed orientated and excellent time management skills Additional Information About the Department Biologics Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10–15-year time horizon. With a robust portfolio of biosimilar products across key therapeutic areas, covering ~US$80+ Bn in innovator sales – future business pipeline covers a variety of product classes and therapy areas, and new modalities. Fully integrated organization with over two decades of experience in developing, manufacturing and commercializing multiple biosimilar products. With a Product Development engine that has end-to-end capabilities – in-house clone development, upstream and downstream process development, bioanalytical development and proprietary formulation. Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs. We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure Rich experience of commercializing high-quality biosimilars in multiple markets with over 900,000 patients having benefited from our products till date. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

Project Role : Software Development Engineer Project Role Description : Analyze, design, code and test multiple components of application code across one or more clients. Perform maintenance, enhancements and/or development work. Must have skills : SAP HCM Payroll Good to have skills : NA Educational Qualification : 15 years of full time education Summary :As a Software Development Engineer, you will engage in a dynamic work environment where you will analyze, design, code, and test various components of application code across multiple clients. Your day will involve collaborating with team members to ensure the successful implementation of enhancements and maintenance tasks, while also contributing to the development of new features that meet client needs. You will be responsible for troubleshooting issues and ensuring the quality of the application through rigorous testing and validation processes, all while adapting to the evolving requirements of the projects you are involved in. Roles & Responsibilities:- Expected to perform independently and become an SME.- Required active participation/contribution in team discussions.- Contribute in providing solutions to work related problems.- Collaborate with cross-functional teams to gather requirements and provide technical insights.- Document code changes and maintain comprehensive records of development processes. Professional & Technical Skills: - Must To Have Skills: Proficiency in SAP HCM Payroll.- Strong understanding of payroll processing and compliance regulations.- Experience with SAP HCM modules and integration with other SAP components.- Ability to troubleshoot and resolve issues related to payroll processing.- Familiarity with programming languages relevant to SAP development. Additional Information:- The candidate should have minimum 3 years of experience in SAP HCM Payroll.- This position is based at our Pune office.- A 15 years of full time education is required. Qualification 15 years of full time education

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy Years of Experience: 1 to 3 years Language - Ability: English(International) - Advanced About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. What are we looking for Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Sr Analyst Qualifications: Bachelor of Pharmacy Years of Experience: 5 to 8 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.In this role, you will be expected to create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Ability to establish strong client relationshipAbility to work well in a teamCollaboration and interpersonal skills Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy

Project Role : Software Development Engineer Project Role Description : Analyze, design, code and test multiple components of application code across one or more clients. Perform maintenance, enhancements and/or development work. Must have skills : SAP HCM Payroll Good to have skills : NA Educational Qualification : 15 years of full time education Summary :As a Software Development Engineer, your typical day will involve analyzing, designing, coding, and testing various components of application code for multiple clients. You will engage in maintenance and enhancement tasks, ensuring that the applications function optimally and meet client requirements. Collaboration with team members will be essential as you contribute to the development process and address any challenges that arise during the project lifecycle. Roles & Responsibilities:- Expected to perform independently and become an SME.- Required active participation/contribution in team discussions.- Contribute in providing solutions to work related problems.- Collaborate with cross-functional teams to gather requirements and provide technical insights.- Document code changes and maintain clear communication with stakeholders regarding project status. Professional & Technical Skills: - Must To Have Skills: Proficiency in SAP HCM Payroll.- Strong understanding of payroll processing and compliance regulations.- Experience with SAP HCM modules and integration with other systems.- Ability to troubleshoot and resolve issues related to payroll processing.- Familiarity with programming languages relevant to SAP development. Additional Information:- The candidate should have minimum 3 years of experience in SAP HCM Payroll.- This position is based at our Kolkata office.- A 15 years of full time education is required. Qualification 15 years of full time education

Watson Pharma Private Limited. is looking for Medical Writing Associate to join our dynamic team and embark on a rewarding career journey Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available data. Preparation of operating budgets, financial statements, and reports. Reviewing existing financial policies and procedures to ensure regulatory compliance. Providing assistance with payroll administration. Keeping records and documenting financial processe

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Associate Qualifications: BE/BTech/BCA Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be part of our Life Sciences R&D division, which offers a comprehensive range of services across the life sciences sector. This includes Clinical Data Management, regulatory services, pharmacovigilance, and patient services solutions. Employees within this clinical capability will join one of our sub-offerings, such as Clinical Database build and Clinical Reporting. In these roles, you will support leading biopharma companies in realizing their vision, enhancing outcomes by focusing on the patient and integrating scientific expertise with unique insights into the patient experience.The Clinical Reports Programming team is dedicated to developing and maintaining clinical reports for clinical trials. This involves utilizing PL/SQL, SQL, and Clinical SAS programming skills to create these reports. The team also integrates data from various sources such as EDC, Labs, and IRT. Ensuring that all reports comply with regulatory standards and guidelines is a crucial part of their work. They implement stringent quality assurance processes to uphold the highest levels of data integrity and report accuracy. Additionally, the team collaborates closely with clinical operations, biostatistics, and other departments to ensure the reports meet the needs of all stakeholders, facilitating informed decision-making based on accurate and timely data.Develop and review complex reports, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for Oracle Procedural Language Extensions to SQL (PLSQL)Structured Query Language (SQL)Experience in writing programs using Clinical SASClinical Database ProgrammingClinical Data ManagementSAS ClinicalAdaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to establish strong client relationshipAgility for quick learning Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification BE,BTech,BCA

Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Associate Qualifications: BCom/MCom/Master of Business Administration Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do We help clients address quality and productivity issues, keep pace with customer expectations, navigate regulatory and operational pressures and ensure business sustainability by transforming their banking operations into an agile, resilient operating model.The Corporate banking /Wholesale banking team is responsible for helping clients and organizations processes trade finance transactions by providing superior service delivery to trade customers whilst safeguarding the bank from risks associated with this business.Identify and assess, prevent and mitigate and account to provide reasonable measures to adapt before executing an agreement in relation to the real estate and immovable property. Valuation of commercial real estate using software like Argus, extracting key information from lease agreements (including amendments) and rent rolls. What are we looking for Adaptable and flexibleAbility to perform under pressureAgility for quick learningAbility to work well in a teamCommitment to quality Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification BCom,MCom,Master of Business Administration

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Specialist Qualifications: BE Years of Experience: 7 to 11 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.Develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for Generative AI, LLM (Large Language Model), Python skills along with OOPS concept. Understands framework and have understanding on agentic AI building. Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification BE

Career Category Information Systems Job Description ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world s toughest diseases, and make people s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what s known today. ABOUT THE ROLE Role Description: The Data Strategy and Governance Lead will operationalize the Enterprise Data Council vision across specific domains (Research, Clinical Trials, Commercial, etc.). He/She will coordinate activities at the tactical level, interpreting Enterprise Data Council direction and defining operational level impact deliverables and actions to build data foundations in specific domains . The Data Strategy and Governance Lead will partner with senior leadership and other Data Governance functional leads to align data initiatives with business goals. He/she will establish and enforce data governance policies and standards to provide high-quality data, easy to reuse and connect to accelerate AI innovative solutions to better serve patients . Roles & Responsibilities: Responsible for data governance and data management for a given domain of expertise (Research, Development, Supply Chain, etc.). Manage a team of Data Governance Specialists and Data Stewards for a specific domain. Responsible for operationalizing the Enterprise data governance framework and aligning broader stakeholder community with their data governance needs, including data quality, data access controls, compliance with privacy and security regulations, foundational master data management, data sharing, communication and change management. Works with Enterprise MDM and Reference Data to enforce standards and data reusability. Drives cross functional alignment in his/her domain(s) of expertise to ensure adherence to Data Governance principles. Provides expert guidance on business process and system design to support data governance and data/information modelling objectives. Maintain documentation and act as an expert on data definitions, data standards, data flows, legacy data structures / hierarchies, common data models, data harmonization etc. for assigned domains. Ensure compliance with data privacy, security, and regulatory policies for the assigned domains Publish metrics to measure effectiveness and drive adoption of Data Governance policy and standards, that will be applied to mitigate identified risks across the data lifecycle (e.g., capture / production, aggregation / processing, reporting / consumption). Establish enterprise level standards on the nomenclature, content, and structure of information (structured and unstructured data), metadata, glossaries, and taxonomies. Jointly with Technology teams, business functions, and enterprise teams (e.g., MDM, Enterprise Data Architecture, Enterprise Data Fabric, etc.) define the specifications shaping the development and implementation of data foundations . Functional Skills: Must-Have Skills: Technical skills with in-depth knowledge of Pharma processes with preferred specialization in a domain (e.g., Research, Clinical, Commercial, Supply Chain, Finance, etc.). Aware of industry trends and priorities and can apply to governance and policies. In-depth knowledge and experience with data governance principles and technology; can design and implement Data Governance operating models to drive Amgen s transformation to be a data driven organization. In-depth knowledge of data management, common data models, metadata management, data quality, reference & master data management, data stewardship, data protection, etc. Experience with data products development life cycle, including the enablement of data dictionaries, business glossary to increase data products reusability and data literacy. Good-to-Have Skills: Experience adopting industry standards in data products. Experience managing industry external data assets (e.g. Claims, EHR, etc.) Ability to successfully execute complex projects in a fast-paced environment and in managing multiple priorities effectively. Ability to manage projects or departmental budgets. Experience with modelling tools (e.g., Visio). Basic programming skills, experience in data visualization and data modeling tools. Experience working with agile development methodologies such as Scaled Agile. Soft Skills: Ability to build business relationships and understand end-to-end data use and needs. Excellent interpersonal skills (team player). People management skills either in matrix or direct line function. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals Good presentation and public speaking skills. Strong attention to detail, quality, time management and customer focus. Basic Qualifications: 12 to 15 years of Information Systems experience 4 years of managerial experience directly managing people and leadership experience leading teams, projects, or programs. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request and accommodation. .

Dear Candidate, We are currently hiring for the position of Senior Medical Write r . Please find the job details below. Job title: Lifesciences Senior Analyst (Senior Medical Writer) Qualifications: PhD in Biotechnology and Pharmaceutical Sciences (Life Sciences); possessing at least 4 years of experience in life sciences / biotech / pharmaceuticals environment with expertise in medical/clinical research writing Location: Mumbai (Andheri East) Onsite Role Work timings: 10:45 am to 7:45 pm Working day: Monday to Friday Position Overview : We are seeking to recruit a Lifesciences Analyst (Medical Writer) with a PhD in Biotechnology and Pharmaceutical Sciences, possessing at least 4 years of experience in a life sciences / healthcare (therapeutics) consulting firm or similar relevant commercial experience in a biotech or pharmaceuticals environment. Experience in writing/producing medical research reports on multiple therapeutic areas, including but not limited to vaccines, immunology, autoimmune disorders, cardiovascular disorders, endocrine disorders, gastrointestinal disorders, infectious diseases, mental health, neurology, oncology, etc. Experience: Proven experience (minimum 4 years) as a medical writer in a biotechnology or pharmaceutical environment. Strong understanding of biotechnology, clinical development processes, multiple therapeutic areas, etc. Ability to adapt writing style to different materials and target audiences. Experience in creating medical content, preferably within an agency or biopharma environment Clear, concise, scientific style of writing, with a high level of attention to detail and excellent language skills Ability to multi-task and work under defined timelines Key Responsibilities / Work Profile: 1. Research, analyze, and interpret scientific literature from research papers and scientific publications, clinical trials, company posters, regulatory filings, and company disclosures to draft a detailed research report from an investment perspective with the following content: company profile and product overview product(s) development pipeline and treatment pathways identify appropriate study endpoints, design, patient populations, and methodology existing treatment profile in the industry treatment mechanism or mechanism of actions of various drugs or therapies comparison of company pipeline with leading marketed therapies and under development alternative pathways in the industry or focused therapeutics / disease articulating clinical trial design and results identifying and recreating relevant charts/diagrams/tables from research papers and scientific publications with the help of graphics designing team and connecting the content with these charts for enhanced understanding organized and precise citations for the research material included in the report event update reports of key development news concise and strategic insights in executive summaries, allowing investors to quickly grasp the content 2. Simplify complex biotech concepts, medical and technical information for investor audiences into clear, understandable documents while maintaining accuracy and depth. 3. Follow/comply with client requirements/SOPs, style guides, client templates, client preferences (as applicable). 4. Manage multiple projects and deliver high-quality reports within deadlines. Only candidates with a PhD are eligible to apply How to Apply: Interested candidates can apply directly on Naukri or send an updated resume to sneha.singh@perusalglobal.com Warm regards, Sneha Singh HR Recruitment Specialist

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : OneTrust Privacy Management Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. You will be responsible for overseeing the application development process and ensuring successful project delivery. Roles & Responsibilities:- Expected to be an SME- Collaborate and manage the team to perform- Responsible for team decisions- Engage with multiple teams and contribute on key decisions- Provide solutions to problems for their immediate team and across multiple teams- Lead the application development process- Ensure timely project delivery- Provide guidance and mentorship to team members Professional & Technical Skills: - Must To Have Skills: Proficiency in OneTrust Privacy Management- Strong understanding of data privacy regulations- Experience in implementing privacy management solutions- Knowledge of data protection laws and compliance requirements- Hands-on experience in configuring privacy management tools Additional Information:- The candidate should have a minimum of 5 years of experience in OneTrust Privacy Management- This position is based at our Bengaluru office- A 15 years full-time education is required Qualification 15 years full time education

About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world s most serious diseases. But we re more than one of the world s leading pharmaceutical companies. Job Description / Capsule Detailed Roles & Responsibilities: Works in close collaboration with the external service provider (CRO) and Investigators to ensure quality and quantity commitments are achieved in a timely and efficient manner. Responsible for ensuring that the study is conducted in accordance with AZ Procedures/ Applicable SOP s & Guidelines, such as ICH and GCP as well as relevant local regulations. Ensure delivery of the projects according to the commitment & set timelines. Initiate, conduct and deliver non interventional studies (local, regional and global) across TAs, External Service Provider Identification, Selection, and Work in close collaboration Initiate ESP contact (CRO, DM and Laboratory), exchange contracts and negotiate costs along with purchase team for DM, monitoring, central lab, translation, printing service, as applicable. Prepare clinical trial budget and get management approval after discussion. Assist in designing of study Protocol, CRF, ICF and other study related documents. Prepare Monitoring Plan, SDV and QC plan for the study. QC review of study documents, CRO and ASV along with CRO person to check QC Budget Preparation & approval. Work with medical colleagues on study protocol and related documents. Ensure quality conduct of the trial/study. Oversee site/Investigator identification and selection and SDV. Ensure Timely delivery of project from study start-up to DBL & CSR. Ensuring compliance with the Protocol, SOPs, ICH-GCP and other applicable regulatory requirements. Regular coordination with CROs to track progress of trial with target and actual milestones. During the trial, to take CAPA to ensure GCP compliance and reliability of data. Publication Management , Adherence to Publication Policy Essential Degree or equivalent professional qualification in related field Pharm D Experience in handling Clinical trials, observational studies, Publication and ESR Desirable Post-graduate qualification

If you join PrimeVigilance, you can expect to work with teams of different sizes, from small clinical trial, to large, generic post-marketing teams. We are always looking for proactive, capable and motivated individuals who aim to surpass any target set in front of them. The PV Officer should be a Life science / bio medical background graduate or have other healthcare related degree qualification (chemistry, biology, biotechnology, veterinary science etc. ) and have demonstrated experience in case processing. The PV Officer will be working as part of a project team, performing, and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance. PV Officers are expected to reach and maintain a high level of performance within 3 months of being assigned to an ICSR team, following onboarding completion. Responsibilities include: Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials, including device and combination products) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines. As a key member there is an expectation to effectively cover all steps of a workflow cycle, except Medical Review. Independent SAE/SUSAR Management (submissions, unblinding, clinical trial reconciliations) Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc. ) Mentoring and training of new and more junior employees within the department, including procedure optimization and development

Position: Senior Medical Coder OVERVIEW Experienced Senior Medical Coder, specializing in MedDRA and WHODrug coding and Serious Adverse Event (SAE) Reconciliation. Proficient in navigating complex medical terminology, collaborating with cross-functional teams, and adhering to industry standards. Proven ability to contribute to the precision and consistency of coded data, ensuring patient safety and compliance with regulatory requirements. Adept at collaborating with cross-functional teams, implementing quality control measures, and contributing to the successful execution of clinical research. KEY TASKS & RESPONSIBILITIES Function as a Coding and SAE subject matter expert providing guidance to clients on best practices, technology, and innovative solutions Design and maintain Medical Coding Guidelines and Serious Adverse Event reconciliation plans in collaboration with sponsors Execute precise and consistent medical coding following coding guidelines and utilizing MedDRA and WHODrug dictionaries Conduct reviews for coding accuracy and consistency reviews including the approval of coded terms and synonym lists Enforce a versioning strategy and timeline for routine updates of industry standard dictionaries (MedDRA and WHODrug) in alignment with medical coding guidelines Assist in maintenance activities for coding tools, including User Acceptance Testing (UAT) script creation and execution Perform testing of coding tool and deployment of Coding /SAE listings in elluminate Ensure adherence to eClinical Solutions/industry quality standards, regulations, guidelines and procedures Perform serious adverse event reconciliation across clinical trial databases, safety systems and other relevant sources Generate coding/SAE queries as necessary Collaborate with safety, clinical, and data management teams to resolve discrepancies and ensure accurate representation of medical coding and safety information Document coding decisions and justifications for clarity and auditability Other duties as assigned Education & Experience Bachelor’s degree in relevant health science or professional qualification in a relevant scientific/technical discipline. 8+ years’ experience in the Pharmaceutical/Biotechnology industry with medical coding experience using WHODrug and MedDRA preferred Knowledge of industry standards, ICH guidelines, and regulatory requirements for medical coding Professional Skills Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology Excellent verbal and written communication skills Detail oriented, ability to multitask with strong prioritization, planning and organization skills Proven ability to work both independently and in a team setting Technical Skills Proficiency in Microsoft Office Applications Experience working on EDC systems. Medidata Rave Coder experience desirable.

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. The SMW will be responsible for authoring the signal management reports including Validations, SERs, HA requests etc. The scientist will support early and late phase development activities as a member of the safety team, providing essential safety oversight and input into all aspects of study management across the entire development and marketed portfolio. In the post-market setting this may include and may include signal evaluation, safety related activities associated with new drug applications/regulatory filings, benefit-risk assessment and safety risk management Perform signal detection review and analysis (qualitative and quantitative) from various sources e.g. regulatory authority database, client database, literatures, regulatory authority websites etc. Responsible for the end-to-end signal management process (i.e. signal tracking, signal assessment/data analysis, leading review meetings, presenting, etc.) in collaboration with the GSO. Conduct/support signal detection and evaluation activities according to SOPs and guidelines Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client’s guidelines, procedures and SOPs, and international drug safety regulations Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for the adverse event reporting Maintaining a good working knowledge of the assigned Clinical studies for narratives Attending/conducting internal, drug safety and project specific training sessions Imparting trainings to the new starts during the induction sessions and the team as required. Skills: Analytical and problem-solving skills Excellent interpersonal skills Excellent verbal / written communication skills Excellent organizational and prioritization skills Ability to work collaboratively and effectively in a team environment Client focused approach to work Ability to evaluate data and draw conclusions independently A flexible attitude with respect to work assignments and new learning Ability to negotiate on behalf of the department to ensure resources, timelines and expectations are aligned Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Fluency in written and spoken English Computer proficiency, IT skills, the expertise and an ability to work with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point) Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. Provides departmental expertise and perspectives to promote prospective business opportunities. Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text Typing and transcription accuracy Knowledge and Experience : Relevant experience is desirable in Regulatory/ Pharmacovigilance or related field. Good knowledge of medical terminologies Education: Science/Medicine degree: The minimum qualification required would be a university degree in life Sciences/Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.) A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage